Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome
NCT ID: NCT02141035
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2015-09-30
2017-09-30
Brief Summary
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Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In severe cases, nerve regeneration and functional recovery are incomplete even with surgery. The goal of this pilot project is to test a potentially promising medication, acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled study design. Along with surgery, those in the treatment group will also receive ALCAR while the other half in the control group will be given placebo. To gauge the effects of ALCAR, we will compare motor and sensory nerve growth as well as functional outcomes. The data from this study will provide crucial information when designing a full scale clinical trial. If successful, this will represent an important first step in finding a novel treatment to improve functional outcomes in patients with severe CTS.
Detailed Description
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Population Adult patients suffering from severe CTS would be a population of the interest. Severity of CTS is defined by clinical symptoms and electromyography (EMG) results. These patients will then be recruited for baseline studies, motor unit number estimation (MUNE). Motor unit number estimation is an EMG technique that quantifies the amount of motor units a muscle contains. In various forms of neuropathies, the MUNE decreases. For our study, patients will be included only if their MUNE is 2 standard deviations below normal. These patients will be identified from referrals to plastic surgery clinics or EMG clinics for management.Pre-study Screening and Baseline Evaluation The subject will have a complete physical exam including clinical labs and an ECG. Only those who have normal laboratory and ECG findings will be enrolled in the study.
Randomization Randomization - After enrollment, patients will be randomized to placebo or acetyl-l-carnitine. A statistician will be employed to develop a randomization sequence. Randomization will be kept on a computer under password encryption. The randomization sequence will only be broken if an adverse event occurs to a patient. At the end of the study the statistician will provide the research team with the randomization sequence codes.
Blinding - The study will be administered in a double-blind manner. The randomization sequence will be kept confidential and only accessible to authorized personnel. Pharmacy will distribute identical pills labelled in bottles with A or B. The research team will be unaware of which contains the study drug or placebo. This will be maintained until the final follow-up has occurred when the research team will be unblinded.
Duration The duration of the study is approximately 13 months for each patient. Screening and baseline evaluation will occur within 1 month preoperatively. The investigators will review and document the screening laboratory tests and ECG results. Acetyl-l-carnitine regimen will begin immediately following surgery. This will be continued for 2 months duration. The patient will then complete follow-up visits at 1, 2, 3, 6, and 12 month intervals. At some of those visits, safety monitoring will include periodic blood chemistries, vital signs and evaluation of overall clinical condition (details shown in table above). All clinically relevant changes occurring during the study will be examined and documented. In cases where laboratory abnormalities are detected, appropriate medical management and advice will be provided.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Acetyl-l-carnitine
Acetyl-l-carnitine will be administered for 2 months duration at a dosage of 3000 mg/d starting at the time of decompression surgery.
Acetyl-l-carnitine
Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days
Placebo
Placebo will be given for 2 months starting at the time of decompression surgery
placebo
The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days
Interventions
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Acetyl-l-carnitine
Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days
placebo
The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days
Eligibility Criteria
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Inclusion Criteria
2. Precipitation of those symptoms by repetitive motions that are relieved by rubbing and or shaking the hands;
3. Nocturnal awakening by those sensory symptoms, or
4. Weakness of thumb abduction and thenar atrophy.
Exclusion Criteria
2. The presence of other neurologic conditions
3. Previous carpal tunnel release surgery
4. Cognitive impairment that renders the patient unable to provide informed consent;
5. Pregnancy
18 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Ming Chan
Professor
Principal Investigators
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Ming Chan, MB,ChB
Role: PRINCIPAL_INVESTIGATOR
Professor, University of Alberta
Locations
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Glenrose Hosptial
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
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References
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Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1.
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Hall SM. The biology of chronically denervated Schwann cells. Ann N Y Acad Sci. 1999 Sep 14;883:215-33.
McKay Hart A, Wiberg M, Terenghi G. Pharmacological enhancement of peripheral nerve regeneration in the rat by systemic acetyl-L-carnitine treatment. Neurosci Lett. 2002 Dec 16;334(3):181-5. doi: 10.1016/s0304-3940(02)00982-5.
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Wilson AD, Hart A, Brannstrom T, Wiberg M, Terenghi G. Primary sensory neuronal rescue with systemic acetyl-L-carnitine following peripheral axotomy. A dose-response analysis. Br J Plast Surg. 2003 Dec;56(8):732-9. doi: 10.1016/j.bjps.2003.08.005.
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Youle M, Osio M; ALCAR Study Group. A double-blind, parallel-group, placebo-controlled, multicentre study of acetyl L-carnitine in the symptomatic treatment of antiretroviral toxic neuropathy in patients with HIV-1 infection. HIV Med. 2007 May;8(4):241-50. doi: 10.1111/j.1468-1293.2007.00467.x.
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Curran MW, Olson J, Morhart M, Sample D, Chan KM. Acetyl-L-carnitine (ALCAR) to enhance nerve regeneration in carpal tunnel syndrome: study protocol for a randomized, placebo-controlled trial. Trials. 2016 Apr 14;17:200. doi: 10.1186/s13063-016-1324-2.
Other Identifiers
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RES0021133
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00045538
Identifier Type: -
Identifier Source: org_study_id